The biosimilars industry is fast-paced and dynamic. Developing a biosimilar requires up-to-date understanding of the regulations and how this regulatory guidance has been interpreted in recent submissions for approval of a follow-on biologic.
Understanding the structural and physicochemical attributes of your biosimilar is often hailed by global leaders in this field as the single most important aspect of the development process. With effective forward planning, biosimilarity/ comparability studies can be designed such that they provide you with quality data that can be relied upon when making key development and regulatory decisions.
In this webinar, leading scientists from the structural and physicochemical fields of biosimilar characterization will describe how and when to perform your biosimilar comparability studies. Particular attention will be paid to the sourcing of innovator material and the important factors to consider when doing this (e.g. expiry dates, number of batches, region of origin etc.)
The presenters will then discuss the critical analyses to be performed in biosimilar comparability studies and the reasons behind including each of these methods. Much of the data obtained from a biosimilarity study can provide orthogonal support to other data sets. This orthogonality becomes especially important if and when you need to explain differences between your biosimilar and the originator.
Anyone who is interested in the exciting field of biosimilar development, or who is working within a team with responsibilities for effective biosimilar characterization and comparability, will benefit strongly from attending this webinar.
Dr. Andrew J. Reason,
CEO and MD, BioPharmaSpec
Following a Ph.D in "Characterization of O-linked GlcNAc in nucleoplasmic and cytoplasmic glycoproteins" and a short period of postdoctoral research at Imperial College, Andrew joined M-Scan in 1994 as a biochemist, and rose to become Managing Director of the M-Scan Limited and M-Scan GmbH laboratories.
Shortly after the acquisition of M-Scan by SGS, Andrew was appointed Group Manager of SGS M-Scan (Europe) and Business Manager for Life Science Services in the UK, managing laboratories in the UK, Switzerland and Germany.
Andrew is Managing Director and CEO of BioPharmaSpec, a CRO he co-founded with Prof. Howard Morris early in 2014. With 25 years of experience in analysis of Protein and Glycoprotein Biopharmaceuticals, Andrew has been involved in:
- Designing programs for characterization of biopharmaceuticals.
- Supplying analytical data, which has been used to support over 100 successful licence applications.
- Developing and pioneering many of the techniques used globally for characterization of biopharmaceuticals.
- Providing consultancy and advice regarding biopharmaceutical characterization.
- Designing and presenting a number of training courses and conference workshops covering analysis of biopharmaceuticals.
In addition to his scientific and managerial duties, Andrew has contributed to many industry publications and is a regular presenter at conferences. He is also a Visiting Professor at the University of Warwick.
Speaker 2: Structural Characterization Expert,
To Be Announced
Speaker 3: Physicochemical Characterization Expert,
To Be Announced
- Understand CQAs: the critical structural and physicochemical attributes to assess
- Understand Innovators: Number of batches, regions and expiry dates to source
- Understand Orthogonality: the importance of presenting orthogonal data
- Understand Characterization: what methods, why and when
- CSO
- CEO/MD
- Heads of Research & Development
- Project Manager
- Analytical Development
- Product Development
- Structural Scientists
- Biophysical Scientists
- Quality Control
- Heads of Outsourcing
- Heads of Biosimilars
- Heads of Discovery
- Protein Sciences
